The first generic of birth control pills Yaz is released

Hyundai, commercializes generic for Yaz

Kolmarpharma conducts bioequivalence test

Low-cost drugs seem to appeal among multiple competitors

Yaz

The first generic for Yaz, a pre-contraceptive drug that has established itself in the market, and Duowell’s generic, a combination drug for hypertension and hyperlipidemia, was released.

 

Generic for Yaz is the first with the same ingredients as the original, but in the case of Duowell’s generics, the same ingredient formulations are already available as drug for data-based re-evaluation.

 

The MFDS approved Hyundai’s Yarose and Kolmarpharma's Telovatin on the 16th.

 

Yaroz is the first generic in Bayer's pre-contraceptive drug Yaz (Drospirenone/Ethinyl estradiol).

 

Hyundai proved equivalence in a bioequivalence test using Yaz as a reference drug.

 

Yaz is the drug with the highest sales value in the domestic pre-contraceptive market.

 

In 2019, IQVIA sales amounted to ₩14.4 billion, which outpaced the rival drug Mercilon (₩9.1 billion) by a big gap.

 

However, Yaz is a Rx drug, so its distribution channel is different from that of the OTC drug Mercilon.

 

Therefore, pharmaceutical companies are commercializing Mercilon as a competitive drug rather than Yaz.

 

Hyundai is the No.

 

1 pharmaceutical company in the market for post-mortem contraceptives that require a doctor's prescription, such as Ellaone and Norebwon.

 

Although it is releasing pre-contraceptive pills in the OTC market, it is far from the leading market.

 

It is analyzed that Hyundai, which has a distribution channel for hospitals and clinics as a post-contraceptive drug, will have a competitive edge in the pre-contraceptive drug market with the generic of Yaz, an Rx drug.

 

Hyundai has been working on Yaz's patent challenge for about 4 years.

 

However, the patent challenge was not successful.

 

Then, when Yaz's patent expired in August last year, it became possible to develop and release generic drugs.

 

Duowell

Kolmarpharma's Telovatin is also the first generic to conduct a bioequivalence test using Duowell as a reference drug.

 

This drug is a combination of Rosuvastatin and Telmisartan.

 

Generics for Rosuvastatin-Telmisartan have already been approved by more than 20 companies and has been released on the market.

 

Ildong, which was licensed for drug for data-based re-evaluation, shared the data, and multiple pharmaceutical companies received permission before PMS (re-examination).

 

Duowell's PMS expired on October 30th.

 

Kolmarpharma’s Telovatin, which was approved this time, is the first generic drug that has been applied for approval after the end of PMS.

 

Generics are expected to be much cheaper than existing generics due to the stepped drug price system.

 

If the drug price is low, sales are detrimental, but it is expected that generics that appeal to low drug prices will continue to emerge in a situation where market competition is severe.